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VitiligoPhase 2NCT04811131

Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo

A Phase 2 study testing ARQ-252 cream 0.3% and NB-UVB phototherapy active treatment in people with Vitiligo, run by Arcutis Biotherapeutics, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will assess the safety and efficacy of ARQ-252 cream in combination with NB-UVB phototherapy treatment in individuals with non-segmental facial vitiligo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vitiligo
What is being tested?
ARQ-252 cream 0.3% and NB-UVB phototherapy active treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
5 sitesUnited States
Study dates
4 Mar 2021to 9 Aug 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is legally competent to sign and give informed consent.
  • Males and females ages 18 years and older (inclusive)
  • Clinical diagnosis of non-segmental vitiligo involving face.
  • A Facial Vitiligo Area Severity Index [F-VASI] score of ≥ 0.25 at baseline.
  • Vitiligo of the face involving at least ≥ 0.25% body surface area (BSA) involvement (ie, one quarter of one handprint). Subjects may have non-facial vitiligo elsewhere which will not be included in the minimum BSA. The maximum BSA (total body inclusive of the face, whether or not in areas to be treated in this study) permitted is 15%.
  • Subjects with vitiligo on the hands, forearms, or elbows agree to treat these areas in addition to the face, with investigational product and phototherapy.
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  • Subject agrees to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the Investigator and camouflage makeups are permitted.
  • Female subject of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline (Visit 2). For FOCBP involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method for at least 4 weeks prior to Day 1. Additionally, from Day 1 until at least 4 weeks after the last investigational product administration, these subjects must agree to use at least 1 highly effective contraceptive method in addition to 1 barrier method.
  • Female subject of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months prior to baseline (post-menopausal status will be confirmed with FSH testing) or have undergone surgical sterilization.
  • Males, if engaging in sexual intercourse with a female who is pregnant or a female of child-bearing potential, must agree to use a condom every time during the study and every time subsequently until 4 weeks beyond the last dose of investigational product.
  • Males must agree not to donate sperm from the first dose of investigational product until 4 weeks after the last dose of investigational product.
  • Subject is in good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.

Who cannot join

  • Subjects who have ever used skin bleaching treatments for treatment of vitiligo or other pigmented areas, eg, depigmenting agents such as monobenzyl ether of hydroquinone, including Benoquin® (Monobenzone)
  • Use of any other prior and concomitant therapy that is a contraindication to phototherapy or may otherwise interfere with the objective of the study as per discretion of the Investigator, such as drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of Baseline (Visit 2).
  • More than 33% leukotrichia in facial lesions (assessed via dermatoscope).
  • Other forms of vitiligo (eg, segmental vitiligo); or other skin depigmentation disorder that would confound study assessments.
  • Use of oral or systemic immunomodulating medications (eg, corticosteroids, azathioprine, methotrexate, cyclosporine) within 8 weeks of Baseline (Visit 2).
  • Use of prescription or over-the-counter topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids, vitamin D derivates, psoralens) within 4 weeks prior to Baseline (Visit 2).
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  • Use of any biological or experimental therapy for vitiligo within 24 weeks of Baseline (Visit 2) (or 5 half-lives, whichever is longer).
  • Use of phototherapy (including laser and tanning beds) within 8 weeks prior to Baseline (Visit 2).
  • Previous oral or topical JAK inhibitor therapy within 24 weeks prior to Baseline (Visit 2), and/or prior non-response to oral or topical JAK inhibitor therapy for vitiligo
  • History of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical treatment for vitiligo.
  • Contraindication to phototherapy, such as photosensitivity disorder (eg, lupus, polymorphic light eruption, solar urticaria, dermatomyositis) or use of photosensitizing or phototoxic medications.
  • Subjects with clinically significant abnormal thyroid-stimulating hormone or free T4 at screening, or otherwise uncontrolled thyroid function at screening as determined by the investigator (Note: If the subject has a history of thyroid disease and is on treatment, the participant must be on a stable thyroid regimen for at least 3 months prior to baseline)
  • History of chronic alcohol or drug abuse within 6 months prior to baseline.
  • Subjects with a cytopenia at screening, defined as follows: Leukocytes < 3 × 10^9/L (2.5 × 10^9/L for subjects who are African-American), Neutrophils < lower limit of normal (<1.5x10^9/L), Lymphocytes < 0.8 × 10^9/L, Hemoglobin < 10 g/dL, Platelets < 100 × 10^9/L.
  • Subjects with current or a history of non-skin cancer within 5 years with the exception carcinoma in situ of the cervix.
  • Subjects with greater than 3 adequately treated nonmetastatic basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) within 12 months prior to Baseline (Visit 2), or a previous history of multiple BCC or SCC on any area of the body, which may pose additional risks from participation in the study, in the opinion of the Investigator.
  • Subjects with previous history of melanoma anywhere on the body, or basal cell carcinoma (BCC), squamous cell carcinoma (SCC), or actinic keratosis (AK) on the face, neck, hands, forearms, or elbows.
  • Subjects that have received live vaccine therapy less than 4 weeks prior Baseline (Visit 2), or anticipate receiving a live or live-attenuated vaccination during the course of the study, have received immunosuppressive drugs less than 4 weeks prior Baseline, or have known infection with mycobacterium tuberculosis, hepatitis B or C, or HIV, or have a diagnosis of an immunodeficiency disorder.
  • Subject had a major surgery within 4 weeks prior to Baseline or has a major surgery planned during the study.
  • Subjects with severe renal insufficiency (as evidenced by estimated glomerular filtration rate <40 mL/min) or with severely impaired liver function (Child-Pugh Class C), ALT or AST ≥ 2 × ULN, total bilirubin > 1.5 x ULN, or total bilirubin > ULN and ≤ 1.5 x ULN AND direct bilirubin is > 35% of total bilirubin, ALP ≥ 2x ULN
  • Subjects with known or suspected hypersensitivity to component(s) of the investigational product.
  • Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of investigational product.
  • Subjects who cannot discontinue the use of strong systemic Cytochrome P-450 CYP3A4 inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin and carbamazepine for 2 weeks prior to Baseline and during the study period.
  • Subjects who cannot discontinue the use of strong systemic Cytochrome P-450 CYP3A4 inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, fluconazole, nefazodone, saquinavir, suboxone and telithromycin for 2 weeks prior to Baseline and during the study period.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Arcutis Site 162

    Austin, Texas, 78759

  • Arcutis Site 167

    Coral Gables, Florida, 33134

  • Arcutis Clinical Site 163

    Pflugerville, Texas, 78660

  • Arcutis Clinical Site 102

    Rolling Meadows, Illinois, 60008

  • Arcutis Site 123

    San Diego, California, 92123

Other trials in United States

About this study

Official title: A Phase 2a, Proof of Concept, 24-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo

This study will assess the safety and efficacy of ARQ-252 cream in combination with NB-UVB phototherapy treatment in individuals with non-segmental facial vitiligo.

Read the detailed description

This study is a Phase 2a, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 0.3% cream in combination with NB-UVB phototherapy treatment in subjects with non-segmental facial vitiligo.

This study was prematurely terminated by the sponsor on 30-Jun-2021.

Conditions
Vitiligo
Being tested
ARQ-252 cream 0.3%, ARQ-252 Vehicle cream, NB-UVB phototherapy active treatment, NB-UVB phototherapy sham treatment
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARQ-252 cream 0.3%Drug

    ARQ-252 cream 0.3%

  • ARQ-252 Vehicle creamDrug

    ARQ-252 Vehicle cream

  • NB-UVB phototherapy active treatmentDevice

    NB-UVB phototherapy active treatment

  • NB-UVB phototherapy sham treatmentDevice

    NB-UVB phototherapy sham treatment

Study groups in NCT04811131
Study groupRoleWhat they receive
Active IP and Active PhototherapyActive comparatorARQ-252 cream 0.3% BID with phototherapy.
Receives: Drug: ARQ-252 cream 0.3%; Device: NB-UVB phototherapy active treatment
Active IP and Sham PhototherapyActive comparatorARQ-252 cream 0.3% BID with sham phototherapy
Receives: Drug: ARQ-252 cream 0.3%; Device: NB-UVB phototherapy sham treatment
Vehicle and Active PhototherapyPlacebo comparatorARQ-252 Vehicle cream BID with active phototherapy
Receives: Drug: ARQ-252 Vehicle cream; Device: NB-UVB phototherapy active treatment
Vehicle and Sham PhototherapyPlacebo comparatorARQ-252 Vehicle cream BID with sham phototherapy
Receives: Drug: ARQ-252 Vehicle cream; Device: NB-UVB phototherapy sham treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving 75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI) Score (F-VASI75) at Week 24

    Achievement of F-VASI75 was declared with a ≥75% improvement from Baseline in F-VASI. F-VASI measures the % of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (none), 10% (only specks), 25% (pigmented area > depigmented area), 50% (depigmented and pigmented areas equal), 75% (depigmented area > pigmented area), 90% (specks of pigment), or 100% (no pigment). F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

    Measured: Week 24

Secondary outcomes (12)

  1. Percentage of Change From Baseline in F-VASI Score

    The mean (SD) percentage change from baseline in F-VASI scores across study time points is presented. F-VASI measures the % of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (none), 10% (only specks), 25% (pigmented area > depigmented area), 50% (depigmented and pigmented areas equal), 75% (depigmented area > pigmented area), 90% (specks of pigment), or 100% (no pigment). F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

    Measured: Weeks 4, 8, 12, 16, 20, and 24

  2. Change From Baseline in Facial Body Surface Area (F-BSA) Score

    The change from baseline in F-BSA affected over time. The endpoint was not assessed due to early study termination.

    Measured: Weeks 4, 8, 12, 16, 20, and 24

  3. Change From Baseline in Vitiligo Noticeability Scale (VNS) Score

    The VNS is a patient-reported measure of vitiligo treatment success, which has a 5-point scale, with 1 being more noticeable and 5 being no longer noticeable. The VNS will be completed for vitiligo on the face. The endpoint was not assessed due to early study termination.

    Measured: Weeks 4, 8, 12, 16, 20, and 24.

  4. Change From Baseline in Vitiligo Quality of Life (VitiQOL)

    Change from Baseline in the VitiQoL, an instrument consisting of 16-item questionnaire (with a 7-point numerical scale from 0 - Not at all to 6 - All of the time) designed to assess disease specific health-related quality of life (HRQL) in patients suffering from vitiligo and also provide an objective measure of disease status, burden of disease, and treatment outcome. The endpoint was not assessed due to early study termination.

    Measured: Weeks 4, 8, 12, 16, 20, and 24

  5. Change From Baseline in Patient Global Impression of Change-Vitiligo (PaGIC-V)

    The PaGIC-V category, a 7-point scale comparing facial vitiligo at baseline with the subject's treated facial vitiligo at the study visit (with 1- very much improved and 7 - very much worse), and time to achieve a PaGIC-V of very much improved or much improved. The endpoint was not assessed due to early study termination.

    Measured: Week 4, 8, 12, 16, 20, and 24

  6. Percentage of Participants Achieving 50% Reduction in F-VASI Score (F-VASI50)

    The percentage of participants achieving F-VASI50. The endpoint was not assessed due to early study termination.

    Measured: Week 4, 8, 12, 16, 20, and 24

  7. Time to Achieve F-VASI50

    The time to achieve F-VASI50. The endpoint was not assessed due to early study termination.

    Measured: Week 4, 8, 12, 16, 20, and 24

  8. Percentage of Participants Achieving 90% Reduction in F-VASI Score (F-VASI90)

    The percentage of participants achieving F-VASI90. The endpoint was not assessed due to early study termination.

    Measured: Week 4, 8, 12, 16, 20, and 24

  9. Achievement of Success in Facial Static Investigator Global Assessment (FsIGA)

    The percentage of subjects with FsIGA, (a four point scale of vitiligo severity for the face only) of clear or almost clear (0 or 1) and time to achieve FsIGA of clear or almost clear (0 or 1). The endpoint was not assessed due to early study termination.

    Measured: Week 4, 8, 12, 16, 20, and 24

  10. Time to Achieve F-VASI75

    The time to achieve F-VASI75 50. The endpoint was not assessed due to early study termination.

    Measured: Week 4, 8, 12, 16, 20, and 24

  11. Achievement of Success in FsIGA Score

    FsIGA of clear or almost clear (0 or 1) plus 2-grade improvement from baseline. The endpoint was not assessed due to early study termination.

    Measured: Week 4, 8, 12, 16, 20, and 24

  12. Time to PaGIC-V Score of Very Much Improved or Improved

    The time to a PaGIC-V score of 1 'very much improved' or 2 'improved'. The PaGIC-V category, a 7-point scale comparing facial vitiligo at baseline with the subject's treated facial vitiligo at the study visit (with 1- very much improved and 7 - very much worse), and time to achieve a PaGIC-V of very much improved or much improved. The endpoint was not assessed due to early study termination.

    Measured: Week 4, 8, 12, 16, 20, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start4 Mar 2021
  3. Primary completion9 Aug 2021
  4. Study completion9 Aug 2021

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a parallel group, double blind, vehicle-controlled study in which subjects with non-segmental vitiligo will be randomized to ARQ-252 0.3% cream BID or vehicle cream BID, and active phototherapy or sham phototherapy for 24 weeks to affected areas of vitiligo on the face, neck, hands, forearms, and elbows, (Up to 15% total body BSA)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811131
Sponsor's protocol ID
ARQ-252-213
Status last verified
Jul 2024
First submitted
18 Mar 2021
Last updated
12 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARQ-252 cream 0.3% and NB-UVB phototherapy active treatment in people with Vitiligo, run by Arcutis Biotherapeutics, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving 75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI) Score (F-VASI75) at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04811131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.

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